MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2004-02-04 for SUBTALAR M.B.A. 05-0109 manufactured by Kinetikos Medical, Inc..
[310177]
On feb. 04, 2003, k. M. I. Was notified of the explant of a 9mm mba 10 months after its original implant date to address pain reported by the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028840-2004-00006 |
| MDR Report Key | 510292 |
| Report Source | 05,06 |
| Date Received | 2004-02-04 |
| Date of Report | 2004-02-04 |
| Date of Event | 2004-01-26 |
| Device Manufacturer Date | 2003-02-01 |
| Date Added to Maude | 2004-02-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 6005 HIDDEN VALLEY RD SUITE #180 |
| Manufacturer City | CARLSBAD CA 92009 |
| Manufacturer Country | US |
| Manufacturer Postal | 92009 |
| Manufacturer Phone | 4481706 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUBTALAR M.B.A. |
| Generic Name | ORTHOPAEDIC FOOT IMPLANT |
| Product Code | ISH |
| Date Received | 2004-02-04 |
| Model Number | 05-0109 |
| Catalog Number | 05-0109 |
| Lot Number | 7773-9-7956 |
| ID Number | * |
| Device Expiration Date | 2006-02-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 499242 |
| Manufacturer | KINETIKOS MEDICAL, INC. |
| Manufacturer Address | 6005 HIDDEN VALLEY RD, STE 180 CARLSBAD CA 92009 US |
| Baseline Brand Name | MAXWELL BRANCHEAU ARTHORESIS (MBA) |
| Baseline Generic Name | ORTHOPEDIC FOOT. IMPLANT |
| Baseline Model No | 05-0109 |
| Baseline Catalog No | 05-0109 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-02-04 |